How to create a plain-language summary of a clinical study
The disconnect between healthcare professionals and patients is sometimes disconcerting. Health Care Organisations make informed decisions for their patients after weighing up the available medical knowledge.
This information, however, is often presented in a format laden with technical jargon. Patients on the receiving end are left struggling to understand what the latest research findings mean for their treatment. Even healthcare professionals (HCPs) are not always able to simplify the message enough for patients to understand.
This is why the European Medicines Agency (EMA) now requires Plain Language Summaries (PLS) alongside the full text of all clinical trials. A PLS captures the essence of a complex research study using accessible language. In this article, we share valuable tips for crafting a clear, helpful PLS.
What is a plain language summary?
A Plain Language Summary explains the who, what, when, where and why of a study. This information must be simplified so that any audience member can understand it, from patient to medical professional to policy-maker.
A plain language summary helps HCPs and clinicians quickly, clearly and fully comprehend and communicate the outcomes of the studies. This form of rhetoric reduces barriers to the understanding of scientific and medical information.
The importance of writing in plain language
The audience for a PLS is unlikely to include subject-matter experts. A PLS needs to be written without specialized jargon and use lay language instead. Thanks to PLS, the study findings can be shared widely. By choosing accessible language the PLS makes the outcome of a study understandable to the public. The goal of any plain language summary is always to increase accessibility.
Why is a plain-language summary necessary?
A successful PLS makes a medical study more accessible; this approach contributes to increasing public engagement and trust. The better the public understands the aims and results of a study, the more invested they will be in the outcomes of current and future research.
The EMA requirement to supply a plain-language summary alongside more complex trial data reflects the public’s right to understand scientific advancement and benefits. The European Union Clinical Trials Regulation (CTR) 536/2014, requires sponsors of trials conducted in EU countries to publish summaries of their studies and findings in language understandable by non-experts.
For a PLS to have the highest possible impact, the language must be carefully chosen to suit the audience.
Downsides to a plain language summary
Despite the emerging popularity of the PLS, there are still a few disadvantages to this form of communication. The text-only format will not appeal to visual learners and will have limited impact among audiences who do not speak the language in which it is written. Infographics might prove more useful for international communication.
A plain language summary may deal with research around a niche field or product but it is crucial that the information remains accurate and transparent. The writing should always be in a format which best serves the intended audience.
How to tailor a PLS to the target audience
The first step in creating a PLS – before even beginning to write it – is to understand the audience. This insight will give your work clarity and purpose making the PLS more informative and compelling.
The audience determines the word choice, tone of voice, linguistic complexity, focus and circulation of the PLS. If the dense medical jargon is not adjusted for a lay audience, the summary will not accomplish its goal.
Checklist for a good PLS:
- Use a good template for consistency
- Use readability tools to keep the language clear
- Double check all information and data for accuracy
- Watch out for bias — relay the information neutrally, factually and impartially, equipping your audience to draw their own conclusions
- Use writing tools and resources
Get feedback if possible
It is helpful to ask a focus group or trial participant to read the draft PLS, or to send the draft to a small portion of the wider community to get their feedback before finalising and disseminating the text. Their responses will help determine what works and what is unclear for the chosen target audience.
How to make the information captivating
Last but not least, once the quality and accuracy of the PLS has been checked, it is essential to make sure the PLS is compelling.
There’s no point in writing a detailed PLS if no one is interested in reading it. It needs to hold the audience’s attention so that HCPs, patients and regulatory agencies see it, read it and remember its contents.
Here at SciencePOD, our PLS experts convey the most complex information in an accessible, compelling manner. We offer free consultations so get in touch and start your content creation journey with us.